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临床试验/NCT05928871
NCT05928871招募中4 期

The Effect of Pre-operative Versus Post-operative Misoprostol in Reducing Blood Loss During and After Elective Cesarean Section.

Cairo University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
120
试验地点
1
主要终点
Estimation of Intraoperative and postoperative blood loss.

研究概览

简要总结

Cesarean section is the most common performed major surgical interventions among women all over the world.Cesarean section has many serious complications, including primary postpartum hemorrhage (PPH). Postpartum hemorrhage is one of the most serious causes of maternal mortality and morbidity, especially in developing countries, and the number of maternal deaths due to postpartum hemorrhage is estimated to exceed 100,000 maternal deaths each year. The incidence of CS is increasing and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL) .

The most successful technique for decreasing PPH is active management of the third stage of labor (AMTSL), requires prophylactic utero-tonic drugs as oxytocin, ergometrine malate and combinations of them , They must be administered by injection.

Misoprostol is synthetic prostaglandin (PGE1 analogue), with utero-tonic properties, has been proposed as an alternative strategy for prevention of PPH in settings where oxytocin use is not handy. It has important advantages over oxytocin, including the potential for oral administration and a long shelf life at room temperature.Misoprostol is affordable and widely available, can be easily administered via multiple routes, and has a good safety profile if properly administered and monitored, all of which makes it an alternative treatment option of PPH in developing countries.

Investigators were comparing the effect of preoperative and post-operative rectally administrated misoprostol on operative blood loss at cesarean section. Misoprostol has an important effect in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions.

详细描述

History taking:

  • Verbal consent.
  • Detailed clinical history.
  • Personal history:

Name, Age, Parity, Occupation, Residency and Special habits.

  • Present history: History of onset, course and duration of vaginal bleeding or bloody vaginal discharge, presence of uterine contraction, PROM, IUGR or any indication for cesarean section.

  • Obstetric history: History of previous preterm labor, previous abortion, previous full term deliveries, RH incompatibility, mode of delivery and fetal outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women booked for elective cesarean section not in active labor
  • Scheduled for primary elective caesarian section.
  • No contraindications to prostaglandins.
  • Have no history of coagulopathy.
  • Aged between 18-40 years.
  • Full term pregnancies (GA 37 to 42 weeks).
  • Singleton pregnancies.
  • BMI 20-30 kg/ m2

排除标准

  • Placenta previa.
  • Maternal hypertension and Pre-eclampsia. .
  • Diabetes mellitus.
  • Previous CS and those with active labor.
  • Multiple Fibroid uterus .
  • Multiple pregnancies.
  • Overdistended uterus eg. polyhydramnios
  • Previous myomectomy, previous history of PPH .
  • Contraindication to spinal anesthesia.
  • Blood coagulopathy and bleeding disorder.
  • Marked maternal anemia (Preoperative hemoglobin <9 gm/dl).
  • Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
  • Extreme of BMI (<20 or >30Kg/m2).

研究组 & 干预措施

preop

Active Comparator

60 women: will receive preoperative 600 microgram of misoprostol ( 3 tablets ) rectally after spinal anaesthesia and urinary catheterization and postoperative placebo (3 tablets). (as per WHO dose recommendation)

干预措施: Misoprostol 200mcg Tab (Drug)

postop

Active Comparator

60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation).

干预措施: Misoprostol Pill (Drug)

结局指标

主要结局

Estimation of Intraoperative and postoperative blood loss.

时间窗: 24 hours

calculate total blood loss in guaze and suction bottle

次要结局

  • Need of extra utero-tonic drugs(24 hours)
  • Incidence of postpartum hemorrhage.(24 hours)
  • The incidence of side effects e.g. nausea, vomiting, diarrhea, shivering and headache.(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ahmed nagy shaker ramadan

lecturer

Cairo University

研究点 (1)

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